EMEA-000830-PIP02-10-M02 - paediatric investigation plan

human normal immunoglobulin

Key facts

• Invented name:
  Gammaplex
• Active substance:
  human normal immunoglobulin
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0295/2015
• PIP number:
  EMEA-000830-PIP02-10-M02
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  • Treatment of idiopathic thrombocytopenic purpura as a model for immunomodulation
  • Treatment of primary immunodeficiency (PID) as model for replacement therapy
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/12/2015
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000830-PIP02-10-M02
• Compliance opinion date:
  29/01/2016
• Compliance outcome:
  Positive

Decision

P/0295/2015: EMA decision of 3 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (Gammaplex), (EMEA-000830-PIP02-10-M02)

Adopted Reference Number: EMA/773326/2015